Proposal of the European Commission for a Regulation
concerning the placing of plant protection products on the market
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EU 3 climate zones map COM(2006) 388
On November 24th, 2009 the new Regulation (EC) 1107/2009 concerning the placing of plant protection products on the market was published in the Official Journal of the European Union. It became effective on December 14th, 2009 and has replaced the Directives 91/414/EEC and 79/117/EEC since June 14th, 2011.
The regulation has a direct force of law in the Member States and therefore does not need to be implemented in national law.
Concerning the mutual recognition of registrations and the zonal approach, it is there written (§29):
- To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable.
- Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition.
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However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved.
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The impact of the new regulation in a few words:
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Zonal approach
- In the future, a company will be able to apply for one registration for several countries of the same zone at the same time.
- In this case, one of the member state conducts the registration and the other states grant their approval on the basis of the first evaluation later on, and within a timely registration process (see below).
- For this purpose, the EU is divided into three zones: In the North: Scandinavian and Baltic states; in the South: The Mediterranean countries (except Slovenia) and Bulgaria; in the Middle: All other Member states.
Mutual recognition of registrations
- A company can request a mutual recognition at any time
(In the case the company hadn't chosen the zonal system from the beginning or should it want to extend the registration to ohter states afterwards) - The new Regulation accelerates the registration process by specifying a processing time of 120 days.
